Titan Pharmaceuticals reports total revenues of $2.4M for first-quarter 2010

Titan Pharmaceuticals, Inc.May 17 2010

Titan Pharmaceuticals, Inc. (Pink Sheets: TTNP) today reported financial results for the first quarter ended March 31, 2010.

Total revenues for the first quarter of 2010 were $2.4 million consisting primarily of royalty and grant revenues. The first quarter marked a key milestone for Titan with the commercial launch of Fanapt™ in the U.S. by Novartis, which generated $1.7 million in royalty revenue for Titan. Grant revenue from the National Institutes of Health (NIH) in support of the Phase 3 clinical study of Probuphine® was $0.7 million.

Total operating expenses for the first quarter of 2010 were $2.6 million, compared with $1.1 million for the first quarter of 2009.  The year-over-year increase in expenses resulted primarily from the increased research and development (R&D) expense related to the Phase 3 clinical study of Probuphine® currently in progress, and also an increase in general and administrative (G&A) expense associated with the commencement of operations and re-registration of the Company with the SEC.

Net loss for the first quarter of 2010 was $0.3 million or $0.01 per share, compared with a net loss of $1.1 million or $0.02 per share for the first quarter of 2009.  

At March 31, 2010, the Company had cash and cash equivalents of $1.6 million. Additionally, the royalty and grant revenue to Titan of $2.4 million, which is included in the total accounts receivable at the end of the first quarter, has subsequently been received by Titan.

"During this quarter we have been successful in initiating the confirmatory Phase 3 clinical study of Probuphine and also re-registering the company with the SEC," said Sunil Bhonsle, President of Titan Pharmaceuticals.  "We will continue to make efficient use of our limited resources, and we look forward to further progress in the Probuphine development program," he concluded.  

"The board is pleased with the progress made by the Company, especially the continuation of the Probuphine development program," said Marc Rubin, MD, Executive Chairman of Titan Pharmaceuticals. "We are thankful for the support we have received from NIDA, and for the support and encouragement we have received from leaders working in the field of addiction medicine. We believe that Probuphine has the potential to provide a safe, effective, and important new treatment option for patients with opioid addiction," he added.

First Quarter 2010 Additional Financial Results

R&D expenses for the first quarter of 2010 were approximately $1.7 million, compared with approximately $0.7 million in the first quarter of 2009.  The increase in R&D expenses  primarily reflects the costs of commencing the Phase 3 clinical study of Probuphine and includes $1 million of external expenses such as clinical research organization charges, investigator and review board fees, investigator meeting and other associated expenses. The remaining R&D expenses reflect internal operating costs such as personnel related expenses, meeting and travel expenses and allocation of facility and corporate costs.

G&A expenses for the first quarter of 2010 increased to approximately $0.9 million from approximately $0.5 million in the comparable period of 2009 primarily due to the activities of reestablishing administrative operations and the filing of Titan's Form 10 registration statement with the SEC. The associated expenses include non-cash stock compensation costs, legal fees and consulting and professional fees.

Probuphine: Recent and Upcoming Events

Probuphine is a novel formulation of buprenorphine designed to provide six months of continuous drug delivery with a single administration.  It is in Phase 3 development by Titan for the treatment of opioid addiction and the Company is currently conducting a confirmatory Phase 3 clinical study in the U.S. which is partially funded through a two year $7.6 million NIH grant being administered by the National Institute on Drug Abuse (NIDA). Recent and upcoming events include the following:  

• In March 2010 Titan announced the initiation of a randomized, placebo and active controlled multicenter Phase 3 clinical study of Probuphine in the treatment of opioid addiction. This study is designed to confirm the safety and effectiveness of treatment with Probuphine versus placebo in reducing the use of illicit opioids over the 24 week treatment period, and also to perform a non-inferiority comparison of Probuphine with Suboxone® which is the widely used sublingual formulation of buprenorphine approved for the treatment of opioid addiction. This 250 patient three arm study is currently enrolling patients at 10 sites and by the end of the second quarter is expected to have 23 active sites.  
• Patient enrollment in the Phase 3 study is expected to be completed by the end of 2010 and study completion is expected in early Q3 2011, with results being available soon thereafter.
• On November 30, 2009, Titan received from the United States Patent and Trademark Office (USPTO) a Notice of Allowance for Titan's U.S. patent application directed to the use of Probuphine for the treatment of opiate addiction. According to the USPTO, the patent is projected to issue within the next two to three months. The patent term will be extended by the total number of days between April 30, 2010 and the actual date of issuance.